Sciscione 1999.

Methods	RCT. Computer‐generated allocation sequence. Concealment of allocation by opaque, sealed, consecutively‐numbered envelopes.
Participants	Singleton vertex pregnancies with intact membranes, BS < 6. Term > 28 weeks. Inclusion of women with previous CS.
Interventions	Intracervical PGE2 (0.5 mg) every 6 hours (72 women). Intracervical Foley catheter inflated with 30 mL (77 women).
Outcomes	Spontaneous onset of labour, nausea, maternal discomfort measured with an analogue scale 0‐10, non‐reassuring FHR, hyperstimulation, use of epidural, use of oxytocin, shoulder dystocia, vaginal delivery.
Notes	12 women excluded (6 women in PGE2 group because of use of Foley catheter, 2 removed consent, 1 pre‐eclampsia, 1 BS of 7 and 2 breech). Setting: Medical centre of Delaware, USA. tertiary referral centre, Study period: July 1995 to July 1996 Funding: not reported Declarations of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random allocation.
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not feasible due to nature of intervention
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	No ITT, women excluded because of protocol violation. no missing data.
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes reported
Other bias	Low risk	No other bias detected